the Peri-implant Tissue Changes Around Implants in the Esthetic Zone Using Demineralized Dentin Graft vs Xenograft

NCT06164353 | Unknown DMC

• 1 other identifier: PER6-32
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dentin grafts are categorized into mineralized dentin, partially demineralized dentin matrix (PDDM), and demineralized dentin matrix (DDM). Mineralized dentin can be obtained from a dentin grinder and was found to be less effective in bone formation, while DDM is biocompatible and osteoinductive. Thus, PDDM which requires a partial demineralization process is an interesting point of research to be studied for its ability for contour augmentation in the esthetic zone.

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (1)

• Peri-implant soft tissue esthetics

  By probe measure Pink esthetic score from 0-10 for Mesial papilla, Distal papilla, Level of soft-tissue margin, Soft-tissue contour, Alveolar process and Color Texture

  After 3 months

Secondary Outcomes (1)

• Vertical buccal bone level changes

  after 3 months of surgery

Study Arms (2)

bovine xenograft covered with a collagen membrane

ACTIVE COMPARATOR

The same procedure of implant placement will be performed but xenograft will be used for augmentation. In both groups, the placed graft will be covered with a collagen membrane. Finally, tension free wound closure will be attained after periosteal releasing incision and suturing using 5/0 proline interrupted sutures. An immediate postoperative CBCT scan will be done following the surgical procedure.

Biological: Partially demineralized dentin graft covered with a collagen membrane

Partially demineralized dentin graft covered with a collagen membrane

EXPERIMENTAL

The stored tooth will undergo grinding using the tooth transformer device. The produced particulate dentin graft will be of a particle size 400-800 µm. Afterwards, these particles will undergo partial demineralization by immersion in in 2% HNO3 for 10 minutes. Then, it will be washed twice using phosphate buffered saline. The exposed implant threads will be covered by partially demineralized autogenous dentin graft in the test group

Biological: Partially demineralized dentin graft covered with a collagen membrane

Interventions

Partially demineralized dentin graft covered with a collagen membrane BIOLOGICAL

The stored tooth will undergo grinding using the tooth transformer device. The produced particulate dentin graft will be of a particle size 400-800 µm. Afterwards, these particles will undergo partial demineralization by immersion in in 2% HNO3 for 10 minutes. Then, it will be washed twice using phosphate buffered saline. The exposed implant threads will be covered by partially demineralized autogenous dentin graft in the test group

Partially demineralized dentin graft covered with a collagen membrane; bovine xenograft covered with a collagen membrane

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥20 years.
• Mild smokers \<1 pack of cigarettes a day
• Capable of understanding or signing the informed consent form before surgery and capable of meeting oral cleaning requirements for implant placement
• Healthy individuals with no systemic disease
• Patients who have a single non-restorable tooth in the esthetic zone
• Thin buccal plate of bone \< 1mm prior to tooth extraction indicated for early implant placement with the ability to place a bone level implant able to achieve 35 N cm stability after placement.

You may not qualify if:

• \) A habit of bruxism or inability to achieve requirements for oral cleaning 2) The presence of acute or chronic infection at the site of tooth extraction with lack of treatment for periodontal disease, or x-rays showing loss of alveolar bone on the adjacent teeth 3) Subjects who have a systemic disease which affects bone healing as diabetes and Paget's disease 4) Use of steroid therapy or under current treatment by chemotherapy or radiation therapy to the head and neck (as Bisphosphonates) 5) Pregnant or breastfeeding women

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Rana Saeed Al Qahtani

Cairo, 12511, Egypt

RECRUITING

Study Officials

• rana Sa Al Qahtani, master

  research ethics committee , cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

rana Sa Al Qahtani, master

CONTACT

+201069792005; rana.saeed@dentistry.cu.edu.eg

nesma mo shemis, phd

CONTACT

+201069792005; rana.saeed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Rana Saeed

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 11, 2023
• Study Start: June 19, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

EG (1)